PATENTS IN PLANT BREEDING

Guarding the Green Assets

Raj Hirwani,
Is Head, CSIR’s Unit for Research and Development of Information Products, Pune-411 038 (E-mail: hirwani@urdip.res.in)
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Plant variety management relates to the conservation, use and commercial exploitation of plant varieties by farmers, commercial breeders, governments and relevant research organisations. Plant variety protection is one subset of this broad field that focuses exclusively on knowledge, which can be commercially exploited. In other words, plant variety protection relates to intellectual property rights over plant varieties, which guarantee the rights holders’ exclusive commercial rights for a specific period of time.

In the agricultural field, inventiveness was traditionally based on sharing of biological resources and related knowledge among farmers in most parts of the world. This changed gradually in the early part of the 20th century in certain western countries where a private sector seed industry slowly developed. The development of the private sector in this field led to a call for a form of intellectual property rights protection over plant varieties to give sufficient incentive to the private sector to enter the seed business.

Historically, the patent system has been ill adapted to plant varieties. Plant breeders first sought protection under the industrial patent system. However, a number of technical difficulties were encountered in seeking to apply the rules of a system designed to protect technical inventions to plant varieties, which were thought not to precisely reproduce themselves, and whose appearance can vary depending upon the environment in which they are grown. There were two main reasons why the patent system was seen as inappropriate. First, plant material was not regarded as capable of meeting the requirements of novelty, inventive step and disclosure. Second, it was not thought to be in the public interest to permit such an extensive monopoly over plant varieties, given their societal importance. Underlying this was the view that it was desirable to retain, in so far as it was possible, the tradition of free exchange of new plant material between plant breeding institutes. This would ensure the widest possible dissemination and use of the new combinations of genetic information.

However, the scope of patentable subject matter expanded, slowly and incrementally until it covered plants. There has been a move from a strict prohibition against the patenting nature towards a range of court decisions allowing the patenting of living matter. As a result there has been a progressive accommodation of biotechnology within the legal system.
In the United States of America (US) the Supreme Court noted that there is a clear statutory distinction between products of nature and manmade inventions, rather than between living and inanimate things.

US was the first country to promulgate the Plant Patent Act in 1930 that first allowed for patenting of asexually reproduced cultivars (except tubers). By 1960’s some European countries enacted plant breeders’ rights laws. It was demonstrated that sexually reproduced varieties were uniform and stable enough to be included in these laws. US followed Europe by enacting The Plant Variety Protection (PVP) Act in 1970. Its purpose is to “encourage the development of novel varieties of sexually reproduced plants” by providing their owners with exclusive marketing rights in the US.

UNITED STATES
In the US there are three main ways in which an inventor or breeder may obtain formal IPR on plant material:

Plant Patents
A plant patent is granted by the US Government to an inventor who has invented or discovered and asexually reproduced a distinct and new variety of plant, other than a tuber propagated plant or a plant found in an uncultivated state. The grant, which lasts for 20 years from the date of filing the application, protects the inventor’s right to exclude others from asexually reproducing, selling, or using the plant so reproduced. This protection is limited to a plant in its ordinary meaning:

A living plant organism which expresses a set of characteristics determined by its single, genetic makeup or genotype, which can be duplicated through asexual reproduction, but which can not otherwise be “made” or “manufactured.”

Sports, mutants, hybrids, and transformed plants are comprehended (sports or mutants may be spontaneous or induced). Hybrids may be natural, from a planned breeding program, or somatic in source. While natural plant mutants might have naturally occurred, they must have been discovered in a cultivated area.

The term “plant” has been interpreted to mean “plant” in the ordinary and accepted sense and not in the strict scientific sense. Algae and macro fungi are regarded as plants, but bacteria are not.

Asexual Reproduction
Asexual reproduction is the propagation of a plant to multiply the plant without the use of genetic seeds to assure an exact genetic copy of the plant being reproduced. Any known method of asexual reproduction, which renders a true genetic copy of the plant, may be employed. Acceptable modes of asexual reproduction would include but may not be limited to Rooting Cuttings, Grafting and Budding, Apomictic Seeds, Bulbs, Division, Slips, Layering, Rhizomes, Runners, Corms, tissue Culture and Nucellar Embryos.

The purpose of asexual reproduction is to establish the stability of the plant. This second step of the invention must be performed well in advance of the application for patent rights, to allow for a thorough evaluation of propagules or clones of the claimed plant for stability. This is to assure that such specimens retain the identical distinguishing characteristics of the original plant.

Other Requirements of Patentability:

That the plant was invented or discovered and, if discovered, that the discovery was made in a cultivated area.

That the plant is not a plant, which is excluded by statute, where the part of the plant used for asexual reproduction, is not a tuber food part, as with Irish potato or Jerusalem artichoke.

That the person or persons filing the application are those who actually invented the claimed plant; i.e., discovered or developed and identified or isolated the plant, or asexually reproduced the plant.

That the plant has not been sold or released in the United States of America more than one year prior to the date of the application.

That the plant has not been enabled to the public, i.e., by description in a printed publication in the United States more than one year before the application for patent with an offer to sale; or by release or sale of the plant more than one year prior to application for patent.

That the plant be shown to differ from known, related plants by at least one distinguishing characteristic, which is more than a difference caused by growing conditions or fertility levels, etc.

The invention would not have been obvious to one skilled in the art at the time of invention by applicant.

Due Diligence
Before an application is filed, the (clones of the) plant must have been carefully observed during the testing process. Among the factors which must be ascertained for a reasonably complete botanical description for the claimed plant are:

Other characteristics which distinguish the plant such as resistance(s) to disease, drought, cold, dampness, etc., fragrance, coloration, regularity and time of bearing, quantity or quality of extracts, rooting ability, timing or duration of flowering season, etc.

Rights Conveyed by a Plant Patent
A plant patent is granted on the entire plant. It therefore follows that only one claim is necessary and only one is permitted.

Grant of a patent for a plant precludes others from asexually reproducing or selling or using the patented plant. A plant patent is regarded as limited to one plant, or genome. A sport or mutant of a patented plant would not be considered to be of the same genotype, would not be covered by the plant patent to the parent plant, and would, itself, be separately patentable, subject to meeting the requirements of patentability. As with utility applications, when the plant patent expires after 20 years from the filing date of application, the subject matter of the patent becomes public domain. As a part of patent right, Inventor gets an opportunity to give the Distinctive Name to the variety developed by him.

Utility Patents
Utility patents may be granted in the U.S. for any new plant in which man has had “a hand” in the creation thereof. This follows from the landmark rulings in the Diamond vs. Chakrabarty case and also the Ex-parte Hibberd case. US patent law provides that an entity may make claims to a time-limited right to exclude others from use of plants and plant products, provided that the legal criteria for patentability (novelty, non-obviousness and utility) are met. Utility patents may be used to claim exclusionary rights in new varieties of plants , transgenic plants, plant groups, individual plants and their descendants, particular plant traits, plant parts, plant components (e.g. specific genes or chromosomes), plant products (e.g. fruits, oils, pharmaceu-ticals), plant material used in industrial processes (e.g. cell lines used in cultivation methods), reproductive material (e.g. seeds or cuttings), plant culture cells, plant breeding methodologies, and vectors and processes involved in the production of transgenic plants. Note that this list is only illustrative, and not exhaustive. In the utility patent application, the applicant must fully disclose how to identify, make and use the claimed invention.

EUROPEAN PATENT OFFICE
Standard Patents: In countries that are members of the European Patent Office (EPO), the patenting of plant varieties, per se, is prohibited. Indeed, before a decision by the EPO’s Enlarged Board of Appeals on December 20, 1999, it was assumed that no plants could be a subject of a utility patent claim, based on the Directive 98/44/EC of the European Parliament. However, the EPO, Board Of Appeals (BOA) determined that a claim directed to transgenic plants of more than one variety, but that does not claim an individual plant variety, is permissible. Thus, opening the way, for all intents and purposes for the EPO to allow claims to plants.

AUSTRALIA
SAustralia grants two kinds of patents: Standard Patents and Innovation Patents
Standard Patents: Australia allows the claiming of protection of plants in standard patents, for plants in general and for specific cultivars. The range of patentable subject matter for plants under Standard Patent Applications includes most of the items covered under US Utility Patents.

For inventions relating to plant varieties production include genetic engineering techniques, tissue culture, cell and protoplast culture, mutagenesis and breeding and cultivation methods. A standard patent gives long-term protection and control over an invention for up to 20 years.

Innovation Patents: This relatively fast, inexpensive protection option, lasting a maximum of 8 years was introduced in 2001. Plants and the biological processes for the generation of plants are not patentable subject matter for an innovation patent. However, it is possible to obtain an innovation patent on processes that use a plant or parts of plants, but that does not result in the generation of a plant. In addition to above, Plant Breeders Rights are available for Plant Cultivars only.

JAPANStandard Patents: According to the Japanese patent regulations, in an invention relating to a plant, a claim should be described as follows: In the case of an invention of a plant per se, the plant should be specified by, for example, a combination of any of the species, the distinctive gene of the plant, characteristics of the plant, etc. and may be further specified by the process for creating the plant.

KOREA
The Korean Patent Act, which previously limited the scope of patenx-table plant inventions to “a variety of plant that reproduces itself asexually,” has been abolished by recent amend-ments to the Patent Act, which became effective on October 1 2006. As a result, “any new variety of plant” is eligible for protection if it possesses the necessary requirements of a patent application. This makes a sexually reproductive, genetically altered plant also patentable subject matter, regardless of its reprod-uction method, unless it is deemed contrary to public interest.

In addition to the broadening of the patentable subject matter of plant inventions, the Korean Intellectual Property Office (KIPO) has decided to incorporate a deposit system, allowing plants and seeds to be placed in a depository. Thus, making a deposit can more easily satisfy the description requirement of the reproducibility of a plant invention.

NEW ZEALANDStandard Patents: Plant material, especially transgenic plant varieties, is considered to be patentable Inventions, under the rules for granting utility patents, in New Zealand.

PLANT VARIETY PROTECTION IN OTHER COUNTRIES
With few exceptions, most countries do not permit plant patents. Instead, they offer a protection system that is generally called “plant breeder’s rights.” which include almost all plant types, including sexually and asexually reproducing plants, tubers, and certain hybrids.

INDIA
The World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) requires member states to provide protection for plant varieties either by patents or by an effective sui generis (stand alone) system, or a combination of the two. The International Union for the Protection of New Varieties of Plants (UPOV) also regulates plant breeders’ rights internationally.

By taking into consideration the requirements under TRIPS and the model provided by UPOV India has enacted The Protection of Plant Varieties and Farmers Rights Act (PPVFR) in 2001. For a variety to be eligible for registration under the above act, it must conform to the criteria of novelty, distinctiveness, uniformity and stability (NDUS), as described below:

Novel, if, at the date of filing of the application for registration for protection, the propagating or harvested material of such a variety has not been sold or otherwise disposed of by or with the consent of its breeder or his successor for the purposes of exploitation of such variety (i) in India, earlier than one year, (ii) or outside India, in the case of trees or vines earlier than six years, or, in any other case, earlier than four years, before the date of filing such applications.

Distinct, if it is clearly distinguishable by at least one essential characteristic from any other variety whose existence is a matter of common knowledge in any country at the time of filing of the application.

Uniform, if subject to the variation that may be expected from the particular features of its propagation, it is sufficiently uniform in its essential characteristics.

Stable, if its essential characteristics remain unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end of each such cycle.

The duration of protection of registered varieties is different for different crops which are as follows: For trees and vines (18 years), For other crop (15 years), For extant varieties (15 years) from the date of notification of that variety.

The Act is progressively being implemented; in the initial phase the Government notified some cereal crops and legumes in order to establish the system of listing of plant varieties for the purpose of registration. Last year two fiber crops were added to the list. The criteria for consideration of priority selection of the crops is the crops on which we are dependent for food and nutritional security, including major cereals, pulses, oilseeds, vegetables and fruits crops. Crop species important for India in the world trade, species of Indian origin, crops where India could benefit from introduction of new germplasm and foreign investment.

As of July 2009 end, the Central Government has notified the following crops eligible for registration of varieties (the figures in the bracket indicates the number of applications received).

Out of total 332 applications, 98 are for new varieties, 225 for extant varieties and 9 for farmer’s varieties.
The guidelines for DUS testing of oilseed crops and few other crops have also been notified.

PROTECTION UNDER THE INDIAN PATENTS ACT
India has amended its patent law in conformity to TRIPS agreement and a new law has come into force from 1st January 2005. Under the amended act, patents will also be granted for biochemical, biotechnological and microbiological processes. This means novel biotechnological processes/methods/techniques employed for the development of new plant varieties including transgenic plants can be patented, but, the plants per se are not patentable.